CYANOCOBALAMINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)

Available from:

Mylan Institutional LLC

INN (International Name):

CYANOCOBALAMIN

Composition:

CYANOCOBALAMIN 1000 ug in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test). Sensitivity to cobalt and/or vitamin B12 is a contraindication.

Product summary:

Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows: 10 mL Multiple Dose Vial, NDC 67457-399-10 Box of 1 vial. 10 mL Multiple Dose Vial, NDC 67457-399-25 Box of 25 vials. 30 mL Multiple Dose Vial, NDC 67457-400-31 Box of 1 vial. 30 mL Multiple Dose Vial, NDC 67457-400-05 Box of 5 vials. Store at 20o to 25o C (68o to 77o F). [See USP Controlled Room Temperature.] PROTECT FROM LIGHT. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Bangalore, India JUNE 2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYANOCOBALAMINE- CYANOCOBALAMINE INJECTION
MYLAN INSTITUTIONAL LLC
----------
CYANOCOBALAMIN INJECTION, USP (1,000 MCG/ML)
RX ONLY
DESCRIPTION
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular
or subcutaneous injection.
Each mL contains 1,000 mcg cyanocobalamin, Sodium Chloride 0.9%.
Benzyl Alcohol
1.5%, is present as a preservative. Sodium acetate and Glacial acetic
acid are present as
buffers. Hydrochloric acid and/or sodium hydroxide may have been added
during
manufacture to adjust the pH (range 4.5 to 7.0).
Cyanocobalamin appears as dark red crystals or as an amorphous or
crystalline red
powder or purplish crystalline powder. Sparingly soluble in water and
soluble in alcohol,
practically insoluble in acetone, in chloroform and in ether. It is
stable to autoclaving for
short periods at 121°C. The vitamin B
coenzymes are very unstable in light.
The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the
molecular formula
is C
H
CoN
O
P. The cobalt content is 4.34%. The molecular weight is 1355.4.
The structural formula is represented below.
CLINICAL PHARMACOLOGY
Vitamin B
is essential to growth, cell reproduction, hematopoiesis, and
nucleoprotein
and myelin synthesis.
Cyanocobalamin is quantitatively and rapidly absorbed from
intramuscular and
subcutaneous sites of injection; the plasma level of the compound
reaches its peak
within 1 hour after intramuscular injection. Absorbed vitamin B
is transported via
specific B
binding proteins, transcobalamin I and II to the various tissues. The
liver is
the main organ for vitamin B
storage.
Within 48 hours after injection of 100 or 1,000 mcg of vitamin B
, 50 to 98% of the
injected dose may appear in the urine. The major portion is excreted
within the first eight
12
63
88
14
14
12
12
12
12
12
hours. Intravenous administration results in even more rapid excretion
with little
opportunity for liver storage.
Gastrointestinal absorption of vitamin B
depends on the presence of sufficient intrinsic
factor and calcium ions. Intrins